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Trial record 33 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

Open-label Study of Safety and Tolerability of Memantine in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01999894
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Autism
Pediatric Autism
Intervention Drug: Memantine HCl
Enrollment 102
Recruitment Details Patients who completed the lead-in study MEM-MD-57A (NCT00872898) were eligible to enroll in this study. A total of 19 study centers in the United States enrolled patients.
Pre-assignment Details Patients receiving placebo in the lead-in study underwent a double-blind up-titration targeting same weight-based dose assigned at lead-in study. Patients receiving a stable dose of active were not re-titrated but double-blind was maintained. Patients who were not dosed for more than 3 days between the studies underwent an open-label titration.
Arm/Group Title Memantine
Hide Arm/Group Description Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
Period Title: Overall Study
Started 102
Completed 66
Not Completed 36
Reason Not Completed
Adverse Event             9
Lack of Efficacy             5
Protocol Violation             1
Withdrawal by Subject             7
Lost to Follow-up             10
Other Reason             3
Inclusion/exclusion criteria not met             1
Arm/Group Title Memantine
Hide Arm/Group Description Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Years Number Analyzed 102 participants
9.1  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
15
  14.7%
Male
87
  85.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
White 86
Black 2
Asian 9
American Indian or Alaska Native 0
Native Hawaiian or Other Pacific Islander 1
Other 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
Hispanic or Latino 11
Non-Hispanic or Latino 91
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants
102
1.Primary Outcome
Title Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
Hide Description Number of patients who experienced one or more TEAEs during the study
Time Frame From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.
Arm/Group Title Memantine
Hide Arm/Group Description:
Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: participants
85
Time Frame Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo to Memantine Memantine to Memantine
Hide Arm/Group Description Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups. Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
All-Cause Mortality
Placebo to Memantine Memantine to Memantine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo to Memantine Memantine to Memantine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/50 (2.00%)   0/52 (0.00%) 
Infections and infestations     
Lobar pneumonia  1  1/50 (2.00%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo to Memantine Memantine to Memantine
Affected / at Risk (%) Affected / at Risk (%)
Total   37/50 (74.00%)   37/52 (71.15%) 
Gastrointestinal disorders     
Constipation  1  5/50 (10.00%)  2/52 (3.85%) 
Vomiting  1  6/50 (12.00%)  2/52 (3.85%) 
Diarrhoea  1  4/50 (8.00%)  1/52 (1.92%) 
General disorders     
Irritability  1  2/50 (4.00%)  5/52 (9.62%) 
Pyrexia  1  1/50 (2.00%)  5/52 (9.62%) 
Immune system disorders     
Seasonal allergy  1  7/50 (14.00%)  2/52 (3.85%) 
Infections and infestations     
Nasopharyngitis  1  3/50 (6.00%)  4/52 (7.69%) 
Upper respiratory tract infection  1  5/50 (10.00%)  10/52 (19.23%) 
Ear Infection  1  1/50 (2.00%)  4/52 (7.69%) 
Influenza  1  3/50 (6.00%)  2/52 (3.85%) 
Pharyngitis streptococcal  1  0/50 (0.00%)  4/52 (7.69%) 
Bronchitis  1  3/50 (6.00%)  0/52 (0.00%) 
Investigations     
Weight increased  1  5/50 (10.00%)  4/52 (7.69%) 
Nervous system disorders     
Headache  1  4/50 (8.00%)  3/52 (5.77%) 
Psychomotor hyperactivity  1  3/50 (6.00%)  3/52 (5.77%) 
Psychiatric disorders     
Aggression  1  5/50 (10.00%)  3/52 (5.77%) 
Agitation  1  2/50 (4.00%)  4/52 (7.69%) 
Insomnia  1  5/50 (10.00%)  3/52 (5.77%) 
Stereotypy  1  1/50 (2.00%)  4/52 (7.69%) 
Anxiety  1  3/50 (6.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/50 (10.00%)  5/52 (9.62%) 
Nasal congestion  1  5/50 (10.00%)  3/52 (5.77%) 
Rhinitis allergic  1  2/50 (4.00%)  3/52 (5.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

All data generated in this study are the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

Results Point of Contact
Name/Title: Ephraim Katz, PhD / Associate Director
Organization: Forest Research Institute
Phone: 201-427-8000 ext 8169
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01999894     History of Changes
Other Study ID Numbers: MEM-MD-67
First Submitted: November 26, 2013
First Posted: December 3, 2013
Results First Submitted: January 31, 2014
Results First Posted: March 18, 2014
Last Update Posted: March 18, 2014